Cleared Traditional

K895408 - OPSITE*WOUND (FLEXIGRID APPLICATION SYS...

K895408 is the FDA 510(k) clearance for OPSITE*WOUND (FLEXIGRID APPLICATION SYS... by Smith & Nephew United, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K895408 · Smith & Nephew United, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
99d
Days
Class 1
Risk

K895408 is an FDA 510(k) clearance for the OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM). Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on December 14, 1989 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K895408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date December 14, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 70
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K895408.
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K902010 · Visitec Co. · Jun 1990
DUODERM* ADHESIVE COMPRESSION BANDAGE
K900447 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
LEUKOSILK(TM) SURGICAL TAPE
K896891 · Beiersdorf, Inc. · Feb 1990
LEUKOSPORT(TM) ADHESIVE TAPE
K894367 · Beiersdorf, Inc. · Nov 1989
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
OPSITE I.V. 3000
K895353 · Smith & Nephew United, Inc. · Sep 1989